Study on Patritumab Deruxtecan and Pembrolizumab with Other Cancer Drugs for High-Risk Early-Stage Breast Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

ClinicalTrials ID:NCT06797635

This clinical trial is exploring a new combination of treatments for patients with high-risk early-stage breast cancer that is either triple-negative or hormone receptor-low positive and HER2 negative. The study aims to determine the safety and effectiveness of these treatments before surgery.

Patient Parameters

Program Overview

Researchers are testing new treatments for certain types of early-stage breast cancer, specifically triple-negative and hormone receptor-low positive/HER2 negative breast cancer. The main goals are to see if the combination of patritumab deruxtecan, pembrolizumab, and chemotherapy is safe and well-tolerated, and if it reduces the number of cancer cells removed during surgery compared to just using pembrolizumab and chemotherapy.

Eligibility Criteria

Inclusion Criteria

  • Have locally advanced breast cancer that has not spread to other parts of the body.
  • Have a confirmed diagnosis of triple-negative or hormone receptor-low positive/HER2 negative breast cancer.
  • If you have Hepatitis B, you must have been on antiviral therapy for at least 4 weeks and have an undetectable viral load.
  • If you have a history of Hepatitis C, your viral load must be undetectable.
  • Be in good general health with an ECOG performance status of 0 or 1.
  • Have a heart function of 50% or higher as measured by specific heart tests.

Exclusion Criteria

  • Have uncontrolled heart disease.
  • Have significant eye disease affecting the cornea.
  • Have HIV with a history of certain related diseases.
  • Have previously received certain immune therapies or treatments for the current breast cancer diagnosis.
  • Have metastatic breast cancer or certain advanced nodal involvement.
  • Have another active cancer that has needed treatment in the past 5 years.
  • Have active cancer spread to the brain or spinal fluid.
  • Have a history of lung disease that required steroids or current lung issues.
  • Have an active infection needing treatment.
  • Have both active Hepatitis B and C infections.
  • Have severe breathing problems due to lung illness.

Locations

FACILITYZIPCITYSTATE
Orchard Healthcare Research Inc. ( Site 0006)60077SkokieIllinois
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0003)59102BillingsMontana
Northwest Cancer Specialists (Compass Oncology) ( Site 8003)97223TigardOregon
SCRI Oncology Partners ( Site 7000)37203NashvilleTennessee
Texas Oncology - DFW ( Site 8000)75246DallasTexas
Virginia Oncology Associates (VOA) ( Site 8001)23502NorfolkVirginia

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